From the article: "More than 64,000 patients in the U.S. have been given convalescent plasma,". Not at all sure why the president is required to authorize a medical treatment that's already being widely used?
From the article: "More than 64,000 patients in the U.S. have been given convalescent plasma,". Not at all sure why the president is required to authorize a medical treatment that's already being widely used?
Wow, wonder if this is true? What does everyone think?
Trump reportedly considers fast tracking AstraZeneca vaccine before election
WASHINGTON — The Trump administration is considering fast tracking an experimental coronavirus vaccine developed in the U.K. for use in the United States ahead of the nation’s upcoming presidential election, according to a Financial Times report, which cited three people briefed on the plan.
One option, according to the FT report, would involve the U.S. Food and Drug Administration awarding “emergency use authorization” for the vaccine, which was developed by Oxford University and AstraZeneca.
The latest revelation comes amid reports that Trump on Sunday will announce the emergency authorization of convalescent plasma for Covid-19.
On Saturday, President Donald Trump made a baseless accusation that the FDA was standing in the way of drug companies’ efforts to test potential coronavirus vaccines and treatments for political reasons.
Continued at link
Contact Tracing Is Failing in Many States. Here’s Why.
What would your response be if someone random called you, told you that you were under an order of quarantine, and needed to get a Covid test? This person cannot tell you how he/she got your phone number, and then asks for your address and e mail, to mail your "Order of Quarantine" letter.
I can see how this is going no where in the United States.
The plasma EUA is being done to save lies. If you don't have Covid, you wouldn't need it. The vaccine is different, as a lot of people are anti vax anyway. But anyone with an underlying condition, ( my OH for instance and me as a shielder) would jump at it before winter TYVM.I'll pass thanks- i see political pressure written all over this
Contact Tracing Is Failing in Many States. Here’s Why.
What would your response be if someone random called you, told you that you were under an order of quarantine, and needed to get a Covid test? This person cannot tell you how he/she got your phone number, and then asks for your address and e mail, to mail your "Order of Quarantine" letter.
I can see how this is going no where in the United States.
Several top health officials — led by Dr. Collins, the director of the National Institutes of Health; Dr. Fauci, the government’s top infectious disease expert; and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic. They thought the study’s data to date was not strong enough to warrant an emergency approval.
Senior health officials have privately expressed concern about the rapid growth of the Mayo program and the perceived rush to declare plasma effective without the affirmation of results from randomized trials, which scientists have long relied on as the gold standard of evidence.
We don't answer calls from anyone unknown, and my voice mail has been full for years, so it's a non-starter here.
I definitely think a health alert text is a better option.We don't answer calls from anyone unknown, and my voice mail has been full for years, so it's a non-starter here.
Contact Tracing Is Failing in Many States. Here’s Why.
What would your response be if someone random called you, told you that you were under an order of quarantine, and needed to get a Covid test? This person cannot tell you how he/she got your phone number, and then asks for your address and e mail, to mail your "Order of Quarantine" letter.
I can see how this is going no where in the United States.
Contact Tracing Is Failing in Many States. Here’s Why.
What would your response be if someone random called you, told you that you were under an order of quarantine, and needed to get a Covid test? This person cannot tell you how he/she got your phone number, and then asks for your address and e mail, to mail your "Order of Quarantine" letter.
I can see how this is going no where in the United States.
FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic
FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic
For Immediate Release:
August 23, 2020
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.
Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.
The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.
Alex Azar, Health and Human Services Secretary:
“The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” said Secretary Azar. “The Trump Administration recognized the potential of convalescent plasma early on. Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials. Our work on convalescent plasma has delivered broader access to the product than is available in any other country and reached more than 70,000 American patients so far. We are deeply grateful to Americans who have already donated and encourage individuals who have recovered from COVID-19 to consider donating convalescent plasma.”
Stephen M. Hahn, M.D., FDA Commissioner:
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said Dr. Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
Scientific Evidence on Convalescent Plasma
Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met.
The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.
The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma. The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence.
Terms of EUA
The EUA requires that fact sheets providing important information about using COVID-19 convalescent plasma in treating COVID-19 be made available to health care providers and patients, including dosing instructions and potential side effects. Possible side effects of COVID-19 convalescent plasma include allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.
Mayo Clinic Expanded Access Program
The FDA initially facilitated access to convalescent plasma for treating COVID-19 by using pathways that included traditional clinical trials and emergency single-patient investigational new drug (IND) applications.
An Expanded Access ProgramExternal Link Disclaimer for convalescent plasma was initiated in early April to fill an urgent need to provide patient access to a medical product of possible benefit during a time that the FDA was working with researchers to facilitate the initiation of randomized clinical trials to study convalescent plasma. As the number of single patient IND requests started to number in the hundreds on a daily basis, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol. The program was developed with funding from the HHS’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. To date, the program has facilitated the infusion of over 70,000 patients with convalescent plasma.
The EUA was issued to the HHS Office of the Assistant Secretary for Preparedness and Response.
The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19. The EUA may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
I copied entirely from FDA Government website.
Looking at the Virginia map is very misleading. Two of the counties I see have teachers and a couple of cafeteria workers have tested positive from beach trips. Schools are online in those two counties.
Also Richmond and Henrico Counties are closed, but teachers tested positive on the first day. Henrico closed the schools to teachers and they are working from home. Henrico also, rented all schools to the local YMCA and they are providing care for working parents. The kids are in socially distanced classrooms, and they utilized all other available space.
Working parents in Henrico are upset to say the least. Now they have to pay full child care rates to send their kids to the school for online learning.
If you look at the top left we have many area with no school cases, these schools are in very rural areas, 90% no internet connectivity. They are doing really well, no cases. These communities have really stepped up and most all residents are working hard to keep kids in school.
I think the "no placebo group" has been explained. If it is a life saving treatment akin to a blood transfusion, then there cannot be a placebo group as such. It's not a drug but a procedure, like proning, or oxygenation or a ventilator.Only four days ago:
F.D.A.’s Emergency Approval of Blood Plasma Is Now on Hold
Sudden turn around anyone?
Some of the concerns were such obvious things like no use of a placebo control group. The article is very informative.
Wonder what the traumatic effect is going to be on kids because of social distancing and wearing masks at school. No data yet, of course, but it has to have an effect.Missing school is 'worse than virus for children'
Children are more likely to be harmed by not returning to school next month than if they catch coronavirus, the UK's chief medical adviser says.
Prof Chris Whitty said "the chances of children dying from Covid-19 are incredibly small" - but missing lessons "damages children in the long run".
Millions of pupils in England, Wales and Northern Ireland are due to return to school within weeks.
Prof Whitty also said Covid-19 would be a challenge for at least nine months.
He said it was unlikely there would be a vaccine in 2020 but there was a "reasonable chance" of a successful jab being ready for the following winter in 2021-22.
The government has said all pupils, in all year groups, in England will be expected to return to class full-time in September. Schools have already reopened in Scotland.
- Will pupils do a full school day next term?
- Could reopening schools spread coronavirus?
- Pubs 'may need to shut' to allow schools to reopen
Prof Whitty, who is also England's chief medical officer, said "many more [children] were likely to be harmed by not going than harmed by going" to school.
"There's also very clear evidence from the UK and around the world that children much less commonly get a severe illness and end up having to be hospitalised if they get symptomatic Covid," he added.
Continued at link above.
Below is a report about Scottish schools. Some cases reported but appeared to be outside school transmissions.
Advice 'may change' on face coverings in schools
It is oft repeated that kids are resilient and adaptable, so I hope it will be true in the case of this generation of children living through this pandemic.
When on my trail walks, I sometimes encounter families with their young kids in masks. I have been happily impressed that the kids have not been fussing with the masks at all! So, I think modeling and practice and the attitude of the adults in their lives can “normalize” the mask-wearing and physical distancing safety measures for the children.
Prediction: this virus isn't going to be solely contained in Clark County.The Las Vegas Strip is now a "hotspot" in more ways than one. Where before it was considered a top tourist destination, Las Vegas is gaining a new reputation as ground zero for COVID superspreader events.
According to the Harvard Global Health COVID-19 tracker, Nevada currently has the third-highest concentration of coronavirus cases in the nation. The vast majority of those cases are in Clark County, which houses Las Vegas—meaning the bulk of the state's 65,150 cases and 1,197 deaths have taken place within city limits.
A new study published by the nonprofit news outlet ProPublica looked at anonymized cell phone records of 26,000 individuals in Las Vegas and found that within four days' time, at least 8,000 of those cell phones had dispersed to all but one state in the continental U.S. Though the study didn't specifically track whether those travelers were infected with coronavirus, it stands to reason that the city's major outbreak combined with excessive travel could spell disaster for the rest of the nation.
In a recent interview with NPR hosts Ari Shapiro and Will Stone, Nevada Gov. Steve Sisolak maintained that the reopening of the Las Vegas Strip was rolled out safely. Yet NPR analysts concluded that the city might face a hospital shortage if it continues on its current path. "With testing still turning up lots of infections, Las Vegas is on shaky footing. Nevada's rate of new cases relative to its population rivals hard-hit Southern states," said Stone.
This Beloved Tourist Destination Has Become a COVID Superspreader
<rsbm>I copied entirely from FDA Government website.
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